RECRUITING

Ear-Seizure Detection (EarSD) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed study is an investigator-initiated study that aims to measure the accuracy of a wearable seizure detection and prediction device (Ear-Seizure Detection Device (EarSD)) by simultaneous recording with conventional video-EEG (Electroencephalogram) on patients with epileptic seizures in the Epilepsy Monitoring Unit of the hospital.

Official Title

Real-time Seizure Detection, Classification, and Prediction Using a Low-Cost Low-Burden Ear-worn System

Quick Facts

Study Start:2025-03-19
Study Completion:2032-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06598189

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years.
  2. 2. Patients admitted to UMass Memorial Epilepsy Monitoring Unit (EMU) for long term video-EEG monitoring as part of standard care of both focal and generalized epilepsy.
  3. 3. Willing to wear the wearable device.
  4. 4. Ability to provide informed consent
  1. 1. Subjects wearing other ear devices such as hearing aids.
  2. 2. Inability or unwillingness to provide informed consent.
  3. 3. Irritation of the skin where the device is to be placed.
  4. 4. Patients with intracranial electrodes placement.
  5. 5. Prisoners
  6. 6. Cognitive impaired individuals
  7. 7. Pregnant Women
  8. 8. Children (Age 0-17)

Contacts and Locations

Study Contact

Stephanie Stephens
CONTACT
508-856-3939
Stephanie.Stephens1@umassmed.edu
Charles Hill
CONTACT
Charles.hill6@umassmed.edu

Principal Investigator

Felicia Chu, MD
PRINCIPAL_INVESTIGATOR
UMass Neurology Department

Study Locations (Sites)

Ummmc-Memorial Campus
Worcester, Massachusetts, 01655
United States
Ummmc-University Campus
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: Felicia Chu

  • Felicia Chu, MD, PRINCIPAL_INVESTIGATOR, UMass Neurology Department

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19
Study Completion Date2032-12

Study Record Updates

Study Start Date2025-03-19
Study Completion Date2032-12

Terms related to this study

Keywords Provided by Researchers

  • Seizure Detection
  • Central Nervous System Diseases
  • Nervous System Diseases

Additional Relevant MeSH Terms

  • Seizures
  • Epilepsy